This clinical trial studies the impact of a high fiber diet compared to a prebiotic food-enriched diet on bacteria and viruses found in the gut (microbiome) and flu (influenza) vaccine responses. The gut microbiome plays a critical role in the activation and regulation of the immune system. Alterations of diet can have great impacts on gut microbiome function. Diets high in fiber may enhance the microbes found in the gut and improve the body’s immune response to the influenza (flu) vaccine.
Additional locations may be listed on ClinicalTrials.gov for NCT05565586.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine the feasibility of two dietary intervention strategies focused on fiber-rich and prebiotic foods prior to seasonal influenza vaccination. Feasibility is defined by >= 80% of subjects being compliant with the intervention.
SECONDARY OBJECTIVES:
I. To evaluate the effects of each dietary intervention on the composition, diversity and function of the gut microbiome.
II. To assess the effects of each dietary intervention on response to influenza vaccination as measured by vaccine-specific immune response.
III. To assess the effects of each dietary intervention on systemic immunity.
EXPLORATORY OBJECTIVES:
I. To interrogate the overlap between the identified gut microbial and dietary patterns associated with vaccine response and those associated with excellent or poor responses to cancer immunotherapy (from our own published work and internal cohorts).
II. To identify components and determinants of the gut microbiome that could be modulated to enhance vaccine response.
III. To determine how modulation of the gut microbiome can be achieved through fiber and prebiotic-focused dietary changes.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants undergo a high fiber diet for six weeks and receive an influenza vaccine on study. Participants also undergo blood sample and stool collection on study.
ARM II: Participants undergo weekly dietary counseling and a prebiotic food-enriched diet for six weeks and receive an influenza vaccine on study. Participants also undergo blood sample and stool collection on study.
After completion of study intervention, participants are followed up for 4 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorJennifer Ann Wargo
